US8888755B2 - Disposable bag comprising a multilayer film - Google Patents

Disposable bag comprising a multilayer film Download PDF

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Publication number
US8888755B2
US8888755B2 US13/130,176 US200913130176A US8888755B2 US 8888755 B2 US8888755 B2 US 8888755B2 US 200913130176 A US200913130176 A US 200913130176A US 8888755 B2 US8888755 B2 US 8888755B2
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disposable bag
layer
multilayer film
type
bag according
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US20110249916A1 (en
Inventor
Michael Herrenbauer
Manfred Weis
Franz Kugelmann
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Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1668—Details of containers
    • A61M1/167—Flexible packaging for solid concentrates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10—Methods of surface bonding and/or assembly therefor
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]

Definitions

  • the present invention relates to a disposable bag for accommodating a fluid, which comprises a multilayer film, and a device which comprises a support holder for the disposable bag according to the invention, in which the disposable bag is arranged.
  • the present invention also relates to a process for the production of the disposable bag.
  • a dialyzer which has a first flow path for the blood and a second flow path for the dialysis fluid, wherein both flow paths are separated from each other by a semipermeable membrane.
  • the first flow path is part of an extracorporeal blood circulation system with a feed line and a return line for the blood and also optionally a pump supporting the blood flow.
  • the second flow path is connected to equipment feeding and removing the dialysis fluid.
  • Containers of the haemodialysis machines known from the state of the art often consist of glass which, because of the pore-free surface, are superior, as regards hygiene and bacteriology, to other materials.
  • glass is largely resistant to chemicals coming into consideration, can be satisfactorily cleaned and is physiologically harmless.
  • Known haemodialysis equipment is characterized by a relatively simple structure.
  • a disadvantage is that the glass container is relatively expensive to produce.
  • the disinfection of the glass container that is required before the dialysis treatment proves disadvantageous, as a rapid re-use of the container is often necessary. It would therefore be desirable to provide a haemodialysis apparatus in which the apparatus can continue to be used during the required disinfection of the container which contains the dialysis fluids.
  • U.S. Pat. No. 4,767,526 proposes a dialysis machine in which a reservoir in which the dialysis fluid is held is lined with a bag which is discarded after use. This has the advantage that the reservoir is quickly available again after the removal of the bag and the reservoir itself need not be disinfected.
  • EP 1 235 601 B1 describes a bag for holding dialysate in a tank. To introduce this bag into the container, a special folding mechanism is used from which the bag is unfolded from a handy format to form the bag.
  • WO 83/02061 describes a bag made of PVC (polyvinylchloride) with several chambers for peritoneal dialysis. This bag is used for the separate storage of components of the dialysis solution which are removed separately and are to be mixed only when they are administered to the patient. A disadvantage of this bag is that it consists of PVC.
  • Dialysis bags have inlets and outlets in order to be able to drain or feed fresh or used dialysate.
  • creases can form in the bag such that the essential openings are partly or wholly closed.
  • a further problem with the disposable bags of the state of the art is their deficient stability, in particular when they have to accommodate large volumes such as are important in particular for the present invention. This is attributable in particular to the fact that the weight or the pressure which bears on the weld seams increases markedly as the fill quantity increases.
  • a further disadvantage of the known bags is that, because of their size, a large quantity of material needs to be used, which in turn brings with it a large volume of waste.
  • the object of the invention was therefore to provide a disposable bag or a device which is suitable for filling with dialysis fluid which does not require the time-consuming disinfection of the reservoir of the dialysis machine, makes possible a secure, rapid and creasing-free handling when introducing the disposable bag into the reservoir of the dialysis machine in everyday activity in the clinic, requires less material and brings with it a high stability of the bag, i.e. high transport security when inserting and removing the filled disposable bag/device into/from the reservoir.
  • a disposable bag comprising a multilayer film for accommodating a fluid, wherein the multilayer film has a tensile elongation in longitudinal direction of the extrusion of the film of 250% to 850%, preferably 400% to 800%, more preferably 500% to 750% and most preferably 600% to 700%, and in transverse direction of the extrusion of the film of 300% to 1050%, preferably 450% to 1000%, more preferably 600% to 900% and most preferably 700% to 800%.
  • tensile elongation or elongation at break is meant the percentage ratio of the change in length ⁇ L (at break) to the starting length. It expresses the capacity of a material to follow changes in shape without cracking. Tensile elongation is measured in the tensile test according to DIN 53455.
  • a great capacity of the film to change its length in longitudinal direction of the extrusion of the film in the abovementioned range has the advantage according to the invention that, while it is being filled with or emptied of (used or fresh) dialysate, the bag experiences a change in volume without forming cracks before the given upper limits. This brings with it the further advantage that when unfilled only a small amount of material is required, but there is nevertheless a large capacity when filled. A product can thereby be provided which brings with it only a small amount of waste. This is particularly advantageous from environmental points of view.
  • disposable bag any item which makes it possible to accommodate a fluid, a solid and/or a gas for a specific period.
  • a disposable bag is meant within the framework of the present invention any item which is suitable for use at least once in the intended application.
  • multilayer film is meant in the present invention a film which consists of two or more layers of different or the same material which are joined together by adhesion.
  • the multilayer film is built up from 2 to 10 layers, wherein a structure of 2 to 5 layers is more preferred and a structure of 3 or 4 layers is particularly preferred.
  • the multilayer film can be produced according to any process which is known to a person skilled in the art as suitable for the purpose according to the invention.
  • the multilayer film of the disposable bag according to the invention has a tear strength in longitudinal direction of the extrusion of the film of 300 N/mm 2 to 350 N/mm 2 , preferably 310 N/mm 2 to 340 N/mm 2 and more preferably 320 N/mm 2 to 330 N/mm 2 , and in transverse direction of the extrusion of the film of 220 N/mm 2 to 270 N/mm 2 , preferably 230 N/mm 2 to 260 N/mm 2 and more preferably 240 N/mm 2 to 250 N/mm 2 .
  • tear strength is meant tensile stress which is exerted on an item at the moment of tearing.
  • the tear strength is measured in the tensile test according to DIN 53455.
  • a tear strength below the abovenamed lower limit is disadvantageous, as the bag otherwise tears prematurely through overextension.
  • the bag is very tear-resistant above the cited upper limit, it is not sufficiently extensible.
  • the multilayer film of the disposable bag according to the invention preferably has a transverse strain ratio ⁇ in the rubber-elastic state of 0.45 to 0.55, more preferably 0.47 to 0.53 and most preferably 0.49 to 0.51.
  • the transverse strain ratio also called Poisson's ratio, is defined as the ratio of relative change in thickness ⁇ d/d to the relative change in length ⁇ l/l upon exposure to an external force or stress.
  • a further embodiment according to the invention is a disposable bag in which the multilayer film can be extended by up to 500% by a force of preferably 45 N to 60 N, more preferably 48 N to 62 N, most preferably 52 N to 58 N.
  • a weight which corresponds to a specific force in N is applied uniformly to a 15-mm wide film and the change in length measured.
  • a high extensibility has the advantage that the bag is small when unfilled and thus easy to handle.
  • the material requirement is small as a result of the marked extensibility of the material. A simpler manufacture and packaging of the material is thus also made possible.
  • a particularly preferred embodiment of the present invention is also a disposable bag in which the ratio of the external surface of the disposable bag when filled to the maximum to the external surface when unfilled is in the region of preferably 5/1, greater than ⁇ 2/1, more preferably ⁇ 5/1.
  • Typical upper limits are approx. 8/1 to 12/1 e.g. 10/1 or 9/1. However, higher ratios are provided according to the invention.
  • external surface is meant the surface of the bag which can come into contact with its surroundings (air) when filled and also unfilled.
  • the term “when filled to the maximum” is described by the maximum size of the bag at which the bag still just forms no cracks and consequently does not yet tear.
  • the property of the increase in surface depending on the quantity filled ensures that the multilayer film of the bag is always under pressure during filling, with the result that as it increasingly filled this pressure increases and any folds in the multilayer film which are present when unfilled increasingly disappear.
  • This has the advantage according to the invention that a crease-free introduction of the disposable bag into a reservoir of a medical apparatus, in particular dialysis machine, is ensured. Thus the complete removal of the fluid from the bag is also ensured.
  • a further embodiment of the present invention is also a disposable bag in which the ratio of the capacity of the disposable bag when filled to the maximum to the capacity in the state in which the multilayer film is unextended is preferably ⁇ 3/1, for preference ⁇ 5/1.
  • Typical non-limiting ranges are 3/1 to 12/1, more preferably 5/1 to 11/1, still more preferably 7/1 to 10/1 and most preferably 8/1 to 9/1.
  • volume in the state in which the multilayer film is unextended is meant the volume which can be poured into the bag without an extension of the multilayer film.
  • the disposable bag of the abovenamed embodiments preferably has a capacity in when filled to the maximum in the range of 30 L to 120 L, particularly preferably 40 L to 110 L, still more preferably 50 L to 100 L, further preferably 60 L to 90 L and most preferably 70 L to 80 L.
  • the disposable bag of the present invention can contain one chamber or more than one (several) chambers.
  • severe is meant the presence of at least 2 chambers.
  • the disposable bag can have as many chambers as appears suitable to a person skilled in the art for the respective intended use.
  • the disposable bag preferably contains 1 to 10 chambers, preferably 2 to 6 chambers, more preferably 2 to 4 and most preferably 2 or 3 chambers.
  • the disposable bag contains only one chamber, two disposable bags can also be used in the dialysis machine, one for the preparation of fresh dialysate and one into which used dialysate is recycled. However, if the disposable bag contains several chambers, preferably one of the chambers is used for the preparation of fresh dialysate, and one chamber for collecting used dialysate.
  • Such a use of the bag(s) according to the invention has the advantage that a separation of fresh and used contents is possible and thus no cross-contamination occurs.
  • there is no need to drain water at the place of use because as a result of using one bag with several chambers or two or more bags with one chamber the used dialysate can be collected in one chamber.
  • the individual chambers are preferably likewise manufactured from parts of the multilayer film as defined in more detail below.
  • a preferred embodiment of the disposable bag is equipped with chambers which are arranged in longitudinal direction of the disposable bag.
  • the individual chambers can each have one or more feed and drainage line(s), wherein it is preferred that—particularly in the case of a disposable bag with 2 chambers—at least one chamber has a feed line and the other chamber has a drainage line.
  • each individual chamber can also have a feed and drainage line.
  • the feed and drainage line(s) can be welded fast to the disposable bag or else be fixedly or removably connected via a sealing system.
  • the hose connections to the disposable bag can be conventional connectors. Decisive is that the disposable bag can be rapidly attached to the feed and drainage line(s) or removed again to replace the disposable bag. However, it is also possible that the feed and drainage line system is formed in one piece with the disposable bag.
  • the multilayer film of a disposable bag comprises a type (A) layer which contains several components, wherein one of the components is selected from the group which consists of styrene-isoprene block copolymers, styrene-ethylene-butylene-styrene block copolymers, styrene-ethylene-butylene block copolymers, styrene-ethylene-propylene block copolymers and mixtures thereof, and a further component is selected from the group which consists of polyethylene and a statistical copolymer which comprises ethylene units.
  • A type (A) layer which contains several components, wherein one of the components is selected from the group which consists of styrene-isoprene block copolymers, styrene-ethylene-butylene-styrene block copolymers, styrene-ethylene-butylene block copolymers, styrene-ethylene-propylene block copolymers
  • the further component in the type (A) layer is particularly preferably a statistical copolymer which consists of ethylene and octene units.
  • the proportion of one component in the type (A) layer can be in the range of 35% to 99.99%, preferably 50% to 99.9%, more preferably 55% to 99%, still more preferably 60% to 95% and most preferably 60% to 90%, relative to the total composition of the type (A) layer.
  • the further component in the type (A) layer can thus be in the range of 0.01% to 65%, preferably 0.1% to 50%, more preferably 1% to 45%, still more preferably 5 to 40% and most preferably 10% to 40%, relative to the total composition of the type (A) layer.
  • the multilayer film also preferably comprises one or more type (B) layers which contains several components independently of one another, wherein one of the components is selected from the group which consists of styrene-ethylene-butylene block copolymers (SEBs), styrene-ethylene-butylene-styrene block copolymers (SEBSs), styrene-ethylene-propylene block copolymers (SEPs), styrene-isoprene-styrene block copolymers (SISs) and mixtures thereof, and a further component is selected from the group which consists of polypropylene and a statistical copolymer which comprises propylene units.
  • SEBs styrene-ethylene-butylene block copolymers
  • SEBSs styrene-ethylene-butylene-styrene block copolymers
  • SEPs styrene-ethylene-propylene block copolymers
  • SISs
  • the further component in the type (B) layer consists of a statistical copolymer which comprises propylene and ethylene units.
  • Films with a type (B) layer are advantageous in respect of their high extensibility.
  • the proportion of one component in the type (B) can be in the range of 35% to 99.99%, preferably 50% to 99.9%, more preferably 55% to 99%, still more preferably 60% to 95% and most preferably 60% to 90%, relative to the total composition of the type (A) layer.
  • the further component in the type (B) layer can thus lie in the range of 0.01% to 65%, preferably 0.1% to 50%, more preferably 1% to 45%, still more preferably 5 to 40% and most preferably 10% to 40%, relative to the total composition of the type (B) layer.
  • the multilayer film is preferably built up from a laminate of 3 layers.
  • the middle layer is preferably a layer of the abovenamed type (A).
  • the two external layers which surround the type (A) layer are preferably type (B) layers.
  • These type (B) external layers can have an identical composition or different composition(s) from one another.
  • These films are particularly preferred, as they ensure a uniform extension of the disposable bag according to the invention throughout the filling.
  • polyethylene is meant within the framework of the present invention a thermoplastic produced by the polymerization of ethylene with the simplified chain-structure formula (C 2 H 2 ) n .
  • a copolymer which comprises ethylene units is a polymer produced by copolymerization of ethylene with any chosen further olefin.
  • Polyethylene and a copolymer which comprises ethylene units belong to the group of the polyolefins.
  • the so-called “further olefin” is preferably an ⁇ -olefin which comprises 3 to 20 carbon atoms.
  • Examples of any chosen further olefin are propylene, butene, pentene, hexene, heptene and octene, wherein octene is particularly preferred.
  • polypropylene is meant within the framework of the present invention a thermoplastic produced by polymerization of propylene with the simplified chain-structure formula (C 3 H 6 ) n .
  • a copolymer which comprises propylene units is a polymer produced by copolymerization of propylene with any chosen further olefin.
  • Polypropylene and a copolymer which comprises propylene units belong to the group of the polyolefins.
  • the so-called “further olefin” is preferably an ⁇ -olefin which comprises 2 to 4 carbon atoms.
  • Examples of any further chosen olefin are ethylene, butene, pentene, hexene, heptene and octene, wherein ethylene is particularly preferred.
  • the above-named copolymers which comprise at least ethylene and propylene units are preferably statistical copolymers.
  • a statistical copolymer is a copolymer in which the at least two different monomer units from which the polymer is composed are present copolymerized in a random sequence.
  • block copolymers polymers in which the monomers are not statistically incorporated into the chain but in homopolymeric chain sections which are joined to one another.
  • block polymers include the following: mixed block copolymers of ethylene, propylene, alpha olefins or isoprene and styrene (so-called olefinic styrene block copolymers) or diene-styrene block copolymers such as e.g. SEBS, SEPS, SBS, SEB, SEP and SIS etc.
  • Preferred alternatives to be used in the layer of types (A) and (B) are also elastomeric styrene-butadiene or styrene-isoprene block copolymers, preferably with a diene proportion of over 50 wt.- %, but also for example resinous styrene-butadiene and styrene-isoprene block copolymers, preferably with a diene content of under 50 wt.- %, relative to the total weight of the copolymer.
  • elastomeric styrene-diene block copolymers with a diene content of over 50 wt.- % are used, then their proportion in the mixture is preferably between 20 wt.- % and 40 wt.- % but can also be higher or lower, as required.
  • Resinous styrene-diene block copolymers containing over 50 wt.- % styrene, in particular those with, say, 65 wt.- % to 95 wt.- % styrene are preferably to be contained in a quantity of 40 wt.- % to 60 wt.- % in the moulding compound according to the invention.
  • the disposable film is free from polyvinylchloride.
  • the multilayer film is built up from 3 layers, wherein the first external layer contains 60 wt.- % styrene-ethylene-butylene-styrene (SEBS) copolymer and 40 wt.- % statistical polypropylene-ethylene copolymer, the middle layer 60 wt.- % styrene-ethylene-butylene-styrene block copolymer and 40 wt.- % statistical polyethylene-octene copolymer and the second external layer 60 wt.- % styrene-ethylene-butylene-styrene block copolymer (SEBS) and 40 wt.- % statistical polypropylene-ethylene copolymer.
  • SEBS wt.- % styrene-ethylene-butylene-styrene
  • the multilayer film can be heat-sterilized. It is possible that only one layer of the multilayer film can be heat-sterilized, but two or more or even all the layers of the multilayer film can also be heat-sterilized. It is particularly preferred that at least the layer which forms the inside of the disposable bag according to the invention can be heat-sterilized.
  • heat-sterilizability is meant here that the multilayer film retains both its outer shape and also its mechanical and physico-chemical properties during and after the treatment with steam at a temperature in the range of 100 to 140° C., preferably 110 to 130° C. and a pressure of 1 to 2 bar.
  • the thickness of the multilayer film preferably lies in a range of 1 ⁇ m to 1000 ⁇ m, more preferably from 5 ⁇ m to 800 ⁇ m, particularly preferably from 8 ⁇ m to 500 ⁇ m and most preferably from 10 ⁇ m to 150 ⁇ m. It is possible that the individual layers of the multilayer film each have the same thickness or different thicknesses. It is particularly preferred, in the case of a 3- or more-layered multilayer film, that the two layers forming the outsides have a thickness of ⁇ 40 ⁇ m, preferably ⁇ 20 ⁇ m.
  • the inner layer of a 3- or more-layer film can preferably have a thickness of ⁇ 500 ⁇ m, more preferably of ⁇ 300 ⁇ m and most preferably of ⁇ 100 ⁇ m, whereby a good stability and elasticity is achieved. A high flexibility and load-change resistance is thereby achieved.
  • At least one layer of the multilayer film also has additives and impurities, such as e.g. catalyst residues, at a level under 5000 ppm and under 200 ppm.
  • additives and impurities such as e.g. catalyst residues
  • the respective external layers are formed by heat-sterilizable layers.
  • At least one layer of the multilayer film can be sealed, preferably heat-sealed.
  • the sealing temperature preferably lies in the range of 160° C. to 230° C., more preferably in the range of 180° C. to 210° C.
  • the multilayer film is biocompatible and particularly preferably haemocompatible.
  • the multilayer film is a transparent film.
  • the multilayer film is furthermore preferably free from lubricants, plasticizers, antiblocking agents, antistatics and fillers.
  • the present invention also relates to a device which comprises a support apparatus in which a disposable bag according to the invention is arranged.
  • the support apparatus is preferably such that it supports/stabilizes the disposable bag at those points at which welding points threaten to tear first. The object is thus achieved to remove the disposable bag quickly and safely from the reservoir and to absorb the pressure at the weak points of the bag after it has been filled. In this way it is thus possible to introduce and remove an elastic container without the above-named problems, such as creasing, competently and quickly into and from a reservoir.
  • the support apparatus for accommodating the disposable bag according to the invention preferably comprises a holder which is preferably such that the disposable bag can be attached thereto when filled and also unfilled. Furthermore, the support apparatus must be large enough to be able to also hold the disposable bag in an expanded volume corresponding to the application, i.e. have at least the above-named maximum holding capacity of the disposable bag.
  • the support apparatus has a receiving unit formed as a shaping dish.
  • the shaping dish has a central cylindrical bearing surface to which are connected an outwardly curved upper bearing surface and an outwardly curved lower bearing surface.
  • the shapes of the preferably vessel-like support apparatus are not subject to any limitations. Wholly differently curved and differently shaped insides of the support apparatus can be used if this is required for technical or aesthetic reasons. A secure storage of the dialysate is guaranteed by the elastic bag in every case.
  • the advantage of such a shaping dish is that the pressure of a filled disposable bag possibly found therein is well absorbed.
  • the disposable bag is placed in the shaping dish preferably present in the support apparatus.
  • the bag according to the invention When it is being filled with ready-to-use dialysate the bag according to the invention rests against the wall of the shaped support apparatus and is securely surrounded and supported by same. This security is not guaranteed with previous “batch dialysis” bags.
  • the support apparatus generally contains bicarbonate as a component, a gas pressure is exerted on the bag wall by the gaseous CO 2 in equilibrium with dissolved bicarbonate. CO 2 could escape through the film material and the composition of the dialysate would not be constant. This is effectively prevented by the elastic bag wall resting against the dish of the support apparatus.
  • the support apparatus thus additionally acts as the gas barrier in the systematic arrangement comprising the bag and support apparatus according to the invention.
  • the disposable bag according to the invention is provided at the top and/or bottom end with a holder, preferably in the form of a securing strip, via which it can be secured to the apparatus.
  • the disposable bag can thus be introduced into the apparatus and also removed again. It is particularly preferred that the feed and/or drainage line also be secured via the holder.
  • the holder can be either connected securely to the disposable bag or releasably attached.
  • the holder is also an item which discarded together with the disposable bag according to the invention.
  • the present invention also relates to the use of the disposable bag according to the invention or the device according to the invention for use in an apparatus in for carrying out medical treatment.
  • the apparatus named in the last section is an apparatus for carrying out haemodialysis or peritoneal dialysis, i.e. the medical treatment is haemodialysis or peritoneal dialysis.
  • the present invention also relates to a process for the production of the disposable bottle according to the invention.
  • the process comprises the following steps:
  • the process according to the invention also comprises the step of dividing the multilayer film into several parts. This step is preferably carried out before step b) of the above-defined process.
  • the process according to the invention for the production of a multilayer film according to the invention is characterized in that the multilayer film is preferably produced by coextrusion.
  • the starting materials are mixed, compounded and granulated, before being coextruded preferably on a water-cooled blown-film line.
  • the layers of the multilayer film are coextruded in direct contact with one another. It is also within the framework of the present invention that a protective film produced by coextrusion is attached on one or both sides of the multilayer film. This/these protective film/s can be easily removed or pulled off the multilayer film according to the invention without leaving a residue.
  • the multilayer film can however also be produced in a separate extrusion process, a calendering process or in a film-casting process.
  • the co-extrusion structure can be smoothed immediately after extrusion to produce a smooth surface. If a smoothing is desired, the multilayer film can however also be smoothed by any other process known as suitable to a person skilled in the art.
  • FIG. 1 a disposable bag according to the invention with 2 chambers, each with a feed and a drainage line
  • FIG. 2 a disposable bag according to the invention with a holder in the form of a securing strip.
  • FIG. 3 a disposable bag according to the invention with 2 holders in the form of securing strips.
  • FIG. 4 a force [N]/extension [%] diagram of the multilayer film of the disposable bag according to the invention
  • FIG. 5 a force [N]/extension [%] diagram of comparison film 1.
  • FIG. 6 a force [N]/extension [%] diagram of comparison film 2.
  • FIG. 1 shows a disposable bag according to the invention ( 1 ).
  • the disposable bag according to the invention ( 1 ) is shown in side view.
  • the disposable bag is divided by a dividing wall/dividing film ( 4 ) into 2 chambers, each of which is provided with a feed or drainage line (( 2 ), ( 3 )).
  • FIG. 2 shows the disposable bag according to the invention of FIG. 1 , which is also equipped at the top, to which the feed and drainage line (( 2 ), ( 3 )) are also attached, with a holder ( 5 ) in the form of a holding bar.
  • the holding bar ( 5 ) can also serve to fix the feed and drainage lines (( 2 ), ( 3 )).
  • FIG. 3 shows the disposable bag according to the invention from FIG. 2 , which is also equipped at the bottom with a holder ( 6 ) in the form of a holding bar.
  • FIG. 4 shows a force [N]/extension [%] diagram of the multilayer film of a disposable bag according to the invention.
  • FIGS. 5 and 6 a force [N]/extension [%] diagram of comparison films 1 ( FIGS. 5) and 2 ( FIG. 6 ) is shown.
  • the specimens 1-3 named in the embodiment examples 1 to 5 have the following structure:
  • Specimen 1 is a three-layer film with the following structure:
  • the external layers, and also the characteristic layer of the multilayer film according to specimen 1, contains a styrene-ethylene-propylene (SEP) block copolymer.
  • SEP styrene-ethylene-propylene
  • composition of specimen 1 is as follows:
  • composition of specimen 2 is as follows:
  • the film according to specimen 3 is a commercially available Nissho film. This is a single-layer film with the following composition:
  • the embrittlement temperature of the films was investigated in accordance with DIN 53443 T 2. Specimen 1 showed an incipient brittle fracture at ⁇ 60° C., specimen 2 at ⁇ 65° C. and specimen 3 at ⁇ 60° C.
  • the load-change resistance was determined by tests using a pneumatically-driven test apparatus.
  • the multilayer film was fixed between two halves of a housing. The film lay flat against the bottom of the housing, while a 25-ml spherical cap extended across the top of the housing.
  • the following table 1 shows the gas permeability of specimens 1, 2 and 3 for O 2 and CO 2 , wherein the O 2 gas permeability was determined according to ASTM D-3985, DIN 53380.
  • Example 2 also shows that the multilayer film according to the invention according to specimen 1 displays no measurable tendency to stick during heat sterilization, which is attributable to the fact that the outside layers consist of at least 55% heat-sterilizable styrene-ethylene-propylene block copolymer with an average molecular weight ⁇ 120 000 g/mol and less than 45% polypropylene.
  • a tensile test was carried out with a specimen of the multilayer film of the disposable bag according to the invention. Specimens with a width of 15 mm and a thickness of 120 ⁇ m were tested. The test was carried out with specimens which were die-cut both across the extrusion direction (CD) and along the extrusion direction (MD).
  • the structure of the multilayer film was as follows:
  • the tensile test was carried out according to DIN EN 527 1-3 at a rate of feed of 1 mm/min.
  • Comparison film 1 Specimens with a width of 15 mm and a thickness of 200 ⁇ m (comparison film 1) and 120 ⁇ m (comparison film 2) were likewise tested.
  • the structure of the comparison films was as follows:

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bag Frames (AREA)
  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • External Artificial Organs (AREA)
  • Making Paper Articles (AREA)
  • Packages (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)
  • Materials For Medical Uses (AREA)
US13/130,176 2008-11-20 2009-11-19 Disposable bag comprising a multilayer film Active 2029-12-27 US8888755B2 (en)

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DE102008058272 2008-11-20
DE102008058272A DE102008058272A1 (de) 2008-11-20 2008-11-20 Einwegbeutel umfassend eine Mehrschichtfolie
DE102008058272.7 2008-11-20
PCT/EP2009/008248 WO2010057643A1 (de) 2008-11-20 2009-11-19 Einwegbeutel umfassend eine mehrschichtfolie

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US9861733B2 (en) 2012-03-23 2018-01-09 Nxstage Medical Inc. Peritoneal dialysis systems, devices, and methods
CN103619372A (zh) 2011-03-23 2014-03-05 纳科斯达格医药股份有限公司 腹膜透析系统、装置和方法
CN105208981B (zh) * 2013-03-20 2019-01-08 克里奥瓦克公司 包含具有噪音抑制性质的层的聚合膜
CN105015892A (zh) * 2015-06-01 2015-11-04 马卓娅 一种双用油桶
ES2942732T3 (es) 2015-07-24 2023-06-06 Medtronic Inc Carrito de fluido de infusión para diálisis
US10980930B2 (en) 2015-07-24 2021-04-20 Medtronic, Inc Fluid connectors and fluid flow paths for an infusate caddy
EP3325042A1 (en) 2015-07-24 2018-05-30 Medtronic Inc. Dialysis priming steps using an infusate caddy
WO2018022169A1 (en) * 2016-07-25 2018-02-01 Medtronic, Inc. Infusate holder
DE102018103936A1 (de) * 2018-02-21 2019-08-22 Fresenius Medical Care Deutschland Gmbh Dialysegerät
DE102018103889A1 (de) * 2018-02-21 2019-08-22 Fresenius Medical Care Deutschland Gmbh Zusammenschluss von Lösungsbeuteln für die Dialyse und Verfahren zu deren Befüllung
US11207454B2 (en) 2018-02-28 2021-12-28 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems

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JP2012509119A (ja) 2012-04-19
CA2740648A1 (en) 2010-05-27
ES2394259T3 (es) 2013-01-30
EP2349387B1 (de) 2012-08-29
KR101681656B1 (ko) 2016-12-01
PL2349387T3 (pl) 2013-04-30
ES2479740T3 (es) 2014-07-24
EP2349387A1 (de) 2011-08-03
EP2535068B1 (de) 2014-04-09
CA2740648C (en) 2017-04-18
BRPI0922499B8 (pt) 2021-06-22
JP5785091B2 (ja) 2015-09-24
BRPI0922499B1 (pt) 2020-09-29
US20110249916A1 (en) 2011-10-13
CN102209562B (zh) 2015-11-25
EA020922B1 (ru) 2015-02-27
CN102209562A (zh) 2011-10-05
EA028537B1 (ru) 2017-11-30
BRPI0922499A2 (pt) 2016-07-26
KR20110102882A (ko) 2011-09-19
CO6331417A2 (es) 2011-10-20
PL2535068T3 (pl) 2014-09-30
WO2010057643A1 (de) 2010-05-27
EP2535068A1 (de) 2012-12-19
DE102008058272A1 (de) 2010-05-27
CL2011001163A1 (es) 2012-01-06
EA201400785A1 (ru) 2014-10-30

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